MEN1611 + Cetuximab for Colorectal Cancer (C-PRECISE-01 Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Menarini Group

No Placebo Group

Trial Summary

What is the purpose of this trial?Open-label, dose-confirmation and cohort expansion, multicentre, Phase Ib/II study to assess the anti-tumour activity and safety of MEN1611 in combination with cetuximab for the treatment of patients with PIK3CA mutated metastatic colorectal cancer.

Eligibility Criteria

This trial is for adults with metastatic colorectal cancer that has progressed after treatment with certain chemotherapy and anti-EGFR drugs. Participants must have a specific gene mutation (PIK3CA), no prior PI3K inhibitor treatments, stable heart and lung function, controlled diabetes, and no active severe infections or brain metastases.

Inclusion Criteria

I am fully active or can carry out light work.

My cancer is N-K-RAS and BRAF wild-type but has a PIK3CA mutation.

My cancer returned or worsened after treatment with specific chemotherapy drugs.

My last cancer treatment with anti-EGFR showed partial improvement or stability for 4+ months.

My cancer is a type of colon or rectal cancer.

Exclusion Criteria

I have been treated with a PI3K inhibitor before.

My diabetes is not under control, with high HbA1c and fasting glucose levels.

I have a history of HIV or active hepatitis B or C.

I have a history of serious heart problems that are not under control.

I have ongoing lung problems that are not under control.

I have moderate to severe diarrhea.

I am currently on long-term steroids or other drugs that weaken my immune system.

Treatment Details

The study is testing the combination of MEN1611, a new drug, with Cetuximab in patients whose tumors have a particular genetic change. It's an open-label Phase Ib/II trial which means everyone gets the experimental treatment and researchers track its effectiveness and safety.

1Treatment groups

Experimental Treatment

Group I: MEN1611Experimental Treatment2 Interventions

MEN1611 + Cetuximab

Cetuximab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erbitux for:

Locally or regionally advanced squamous cell carcinoma of the head and neck
Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
BRAF V600E mutation-positive metastatic colorectal cancer

🇪🇺 Approved in European Union as Erbitux for: